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Growth Hormone Research Society Perspective on the Development of Long-Acting Growth Hormone Preparations

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Harvard

Christiansen, JS, Backeljauw, P, Bidlingmaier, M, Biller, B, Boguszewski, M, Casanueva, FF, Chanson, P, Chatelain, P, Choong, CS, Clemmons, DR, Cohen, L, Cohen, P, Frystyk, J, Grimberg, A, Hasegawa, Y, Haymond, M, Ho, K, Hoffman, AR, Holly, JM, Horikawa, R, Hoybye, C, Jorgensen, JOL, Johannsson, G, Juul, A, Katznelson, L, Kopchick, JJ, Lee, K-O, Lee, KW, Luo, X-P, Melmed, S, Miller, B, Misra, M, Popović, V, Rosenfeld, RG, Ross, J, Ross, RJ, Saenger, P, Strasburger, CJ, Thorner, MO, Werner, H & Yuen, KC 2016, 'Growth Hormone Research Society Perspective on the Development of Long-Acting Growth Hormone Preparations', European journal of endocrinology / European Federation of Endocrine Societies, bind 174, nr. 6, s. C1-8. https://doi.org/10.1530/EJE-16-0111

APA

Christiansen, J. S., Backeljauw, P., Bidlingmaier, M., Biller, B., Boguszewski, M., Casanueva, F. F., Chanson, P., Chatelain, P., Choong, C. S., Clemmons, D. R., Cohen, L., Cohen, P., Frystyk, J., Grimberg, A., Hasegawa, Y., Haymond, M., Ho, K., Hoffman, A. R., Holly, J. M., ... Yuen, K. C. (2016). Growth Hormone Research Society Perspective on the Development of Long-Acting Growth Hormone Preparations. European journal of endocrinology / European Federation of Endocrine Societies, 174(6), C1-8. https://doi.org/10.1530/EJE-16-0111

CBE

Christiansen JS, Backeljauw P, Bidlingmaier M, Biller B, Boguszewski M, Casanueva FF, Chanson P, Chatelain P, Choong CS, Clemmons DR, Cohen L, Cohen P, Frystyk J, Grimberg A, Hasegawa Y, Haymond M, Ho K, Hoffman AR, Holly JM, Horikawa R, Hoybye C, Jorgensen JOL, Johannsson G, Juul A, Katznelson L, Kopchick JJ, Lee K-O, Lee KW, Luo X-P, Melmed S, Miller B, Misra M, Popović V, Rosenfeld RG, Ross J, Ross RJ, Saenger P, Strasburger CJ, Thorner MO, Werner H, Yuen KC. 2016. Growth Hormone Research Society Perspective on the Development of Long-Acting Growth Hormone Preparations. European journal of endocrinology / European Federation of Endocrine Societies. 174(6):C1-8. https://doi.org/10.1530/EJE-16-0111

MLA

Vancouver

Author

Christiansen, Jens Sandahl ; Backeljauw, Philippe ; Bidlingmaier, Martin ; Biller, Beverly ; Boguszewski, Margaret ; Casanueva, Felipe F ; Chanson, Philippe ; Chatelain, Pierre ; Choong, Catherine S ; Clemmons, David R ; Cohen, Laurie ; Cohen, Pinchas ; Frystyk, Jan ; Grimberg, Adda ; Hasegawa, Yukihiro ; Haymond, Morey ; Ho, Ken ; Hoffman, Andrew R ; Holly, Jeff Mp ; Horikawa, Reiko ; Hoybye, Charlotte ; Jorgensen, Jens Otto L ; Johannsson, Gudmundur ; Juul, Anders ; Katznelson, Laurence ; Kopchick, John J ; Lee, K-O ; Lee, Kuk Wha ; Luo, Xiao-Ping ; Melmed, Shlomo ; Miller, Bs ; Misra, Madhusmita ; Popović, Vera ; Rosenfeld, Ron G ; Ross, Judith ; Ross, Richard J ; Saenger, Paul ; Strasburger, Christian J ; Thorner, Michael O ; Werner, Haim ; Yuen, Kevin Cj. / Growth Hormone Research Society Perspective on the Development of Long-Acting Growth Hormone Preparations. I: European journal of endocrinology / European Federation of Endocrine Societies. 2016 ; Bind 174, Nr. 6. s. C1-8.

Bibtex

@article{74b8a19c9a2146fea95b496ec043cfa8,
title = "Growth Hormone Research Society Perspective on the Development of Long-Acting Growth Hormone Preparations",
abstract = "OBJECTIVE: The Growth Hormone (GH) Research Society convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting GH preparations (LAGH).PARTICIPANTS: A closed meeting of 55 international scientists with expertise in growth hormone, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry.EVIDENCE: Current literature was reviewed for gaps in knowledge. Expert opinion was utilized to suggest studies required to address potential safety and efficacy issues.CONSENSUS PROCESS: Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees re-convened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors.CONCLUSIONS: LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.",
author = "Christiansen, {Jens Sandahl} and Philippe Backeljauw and Martin Bidlingmaier and Beverly Biller and Margaret Boguszewski and Casanueva, {Felipe F} and Philippe Chanson and Pierre Chatelain and Choong, {Catherine S} and Clemmons, {David R} and Laurie Cohen and Pinchas Cohen and Jan Frystyk and Adda Grimberg and Yukihiro Hasegawa and Morey Haymond and Ken Ho and Hoffman, {Andrew R} and Holly, {Jeff Mp} and Reiko Horikawa and Charlotte Hoybye and Jorgensen, {Jens Otto L} and Gudmundur Johannsson and Anders Juul and Laurence Katznelson and Kopchick, {John J} and K-O Lee and Lee, {Kuk Wha} and Xiao-Ping Luo and Shlomo Melmed and Bs Miller and Madhusmita Misra and Vera Popovi{\'c} and Rosenfeld, {Ron G} and Judith Ross and Ross, {Richard J} and Paul Saenger and Strasburger, {Christian J} and Thorner, {Michael O} and Haim Werner and Yuen, {Kevin Cj}",
year = "2016",
month = mar,
day = "23",
doi = "10.1530/EJE-16-0111",
language = "English",
volume = "174",
pages = "C1--8",
journal = "European Journal of Endocrinology",
issn = "0804-4643",
publisher = "BioScientifica Ltd",
number = "6",

}

RIS

TY - JOUR

T1 - Growth Hormone Research Society Perspective on the Development of Long-Acting Growth Hormone Preparations

AU - Christiansen, Jens Sandahl

AU - Backeljauw, Philippe

AU - Bidlingmaier, Martin

AU - Biller, Beverly

AU - Boguszewski, Margaret

AU - Casanueva, Felipe F

AU - Chanson, Philippe

AU - Chatelain, Pierre

AU - Choong, Catherine S

AU - Clemmons, David R

AU - Cohen, Laurie

AU - Cohen, Pinchas

AU - Frystyk, Jan

AU - Grimberg, Adda

AU - Hasegawa, Yukihiro

AU - Haymond, Morey

AU - Ho, Ken

AU - Hoffman, Andrew R

AU - Holly, Jeff Mp

AU - Horikawa, Reiko

AU - Hoybye, Charlotte

AU - Jorgensen, Jens Otto L

AU - Johannsson, Gudmundur

AU - Juul, Anders

AU - Katznelson, Laurence

AU - Kopchick, John J

AU - Lee, K-O

AU - Lee, Kuk Wha

AU - Luo, Xiao-Ping

AU - Melmed, Shlomo

AU - Miller, Bs

AU - Misra, Madhusmita

AU - Popović, Vera

AU - Rosenfeld, Ron G

AU - Ross, Judith

AU - Ross, Richard J

AU - Saenger, Paul

AU - Strasburger, Christian J

AU - Thorner, Michael O

AU - Werner, Haim

AU - Yuen, Kevin Cj

PY - 2016/3/23

Y1 - 2016/3/23

N2 - OBJECTIVE: The Growth Hormone (GH) Research Society convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting GH preparations (LAGH).PARTICIPANTS: A closed meeting of 55 international scientists with expertise in growth hormone, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry.EVIDENCE: Current literature was reviewed for gaps in knowledge. Expert opinion was utilized to suggest studies required to address potential safety and efficacy issues.CONSENSUS PROCESS: Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees re-convened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors.CONCLUSIONS: LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.

AB - OBJECTIVE: The Growth Hormone (GH) Research Society convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting GH preparations (LAGH).PARTICIPANTS: A closed meeting of 55 international scientists with expertise in growth hormone, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry.EVIDENCE: Current literature was reviewed for gaps in knowledge. Expert opinion was utilized to suggest studies required to address potential safety and efficacy issues.CONSENSUS PROCESS: Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees re-convened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors.CONCLUSIONS: LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.

U2 - 10.1530/EJE-16-0111

DO - 10.1530/EJE-16-0111

M3 - Journal article

C2 - 27009113

VL - 174

SP - C1-8

JO - European Journal of Endocrinology

JF - European Journal of Endocrinology

SN - 0804-4643

IS - 6

ER -

ID: 46346499